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A Double Blind, Randomized, Placebo-controlled, Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effects on Clinical Outcomes of Pegtibatinase (TVT-058), Administered Subcutaneously in Patients With Cystathionine Beta-Synthase Deficient Homocystinuria (COMPOSE)

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Trial Profile

A Double Blind, Randomized, Placebo-controlled, Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effects on Clinical Outcomes of Pegtibatinase (TVT-058), Administered Subcutaneously in Patients With Cystathionine Beta-Synthase Deficient Homocystinuria (COMPOSE)

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 Apr 2024

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At a glance

  • Drugs Pegtibatinase (Primary)
  • Indications Homocystinuria
  • Focus Adverse reactions; Pharmacodynamics; Proof of concept
  • Acronyms COMPOSE
  • Sponsors Travere Therapeutics

    • Most Recent Events

    • 04 Apr 2024 According to a Travere Therapeutics media release, data from the study will be presented at Society for Inherited Metabolic Disorders (SIMD) in Charlotte, North Carolina from April 14-17, 2024, and Genetic Metabolic Dieticians International (GMDI) in Charlotte, North Carolina from April 17-20, 2024.
    • 15 Feb 2024 According to a Travere Therapeutics media release, company will be initiating this ENSEMBLE Study of pegtibatinase in participants with HCU following their completion of the Phase 1/2 COMPOSE Study or the HARMONY Study.
    • 11 Jan 2024 Planned End Date changed from 1 Jun 2025 to 1 Dec 2026.
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